Note: Descriptions are shown in the official language in which they were submitted.
1 3229 1 3
The present invention relstes to devices for controlling urinary
incontinence and to vaginal and rectal prolapse in females.
Particularly, the invention relates to a device which may be removably
inserted into the vagina.
Female urinary incontinence is a common problem and is
particularly prevalent where damage to the bladder or neck of the
bladder has occurred during child birth. In elderly female patients,
urinary incontinence is wide spread.
In normal continent patients, in the erect posture, there is no
descent of the bladder neck below the pelvic floor muscle, thereby
equal distribution of intra-abdominal pressure to the bladder and
bladder neck and pelvic urethra occurs, and continence is maintained.
However, in stress incontinence this is lost due to descent of the
bladder neck below the pelvic floor muscle. On coughing or sneezing or
physical exercise, i.e. when strain is put upon the bladder, an
involuntary spurt of urine is released from the bladder. This
involuntary urine release i8 unpleasant and embarrassing. The released
urine may irritate the groin region and result in an offensive odour.
Vaginal and rectal prolapse are quite common conditions in
females, particularly those who have vaginally delivered one or more
children. These conditions may be painful, and uncomfortable.
Additionally, sexual intercourse may be impaired by occlusion of the
vagina.
It is a generally accepted view that surgical treatment is most
appropriate for cure of stress incontinence and vaginal and rectal
prolapse. However, in elderly or infirm patients the risk of surgery
is too great, so that often these conditions go untreated.
Previously proposed devices to treat incontinence and avoid
recourse to surgery have generally been unsatisfactory. Particularly,
they are cumbersome, difficult to use, need to be replaced frequently,
are inadequate in cases of permanent incontinence and often fail to
prevent involuntary urinary leakage.
A previously known intra-vaginal device for controlling urinary
incontinence in females is disclosed in US patent 4,139,006. This
perviously known device has as its object the deflection of the
urethra. More particularly it has the object of displacing a surface
of the superior wall of the vagina, and an intermediate section of the
X ~
1 322 ~? ~ 3
urethra adjacent thereto, toward to pubic bone, to reduce the urethro-
visicle angle to restore the patient's natural control over the flow of
urine through the urethra from the bladder to the urethral opening.
The device has a pair of forward projections which lie on either side
of the urethra intermediate portion and apply a force thereto to
deflect the intermediate portion of the urethra toward the public bone.
One aspect of the present invention has as its object to provide
an intra-vaginal device to aid in controlling vaginal and rectal
prolapse.
There is disclosed herein an intra-vaginal device, comprising two
limbs interconnected by a flexible base portion so as to be of an
upwardly convex generally "U-shaped~ configuration. One of the limbs
is intended to lie adjacent the anterior vaginal wall and includes a
cradle-like structure to lift the bladder base and bladder neck lying
behind the vaginal wall, without closing the urethra. The other limb is
intended to lie adjacent the posterior vaginal wall and the base
portion has an aperture which, in use, is adjacent the cervix of the
uterus.
The base portion is preferably arch shaped, and is preferably
comprised of a resilient material or has resilient material embedded
within the arch.
Preferably, the cradle-like structure, which lifts the bladder
base and bladder neck, is formed by two protrusions extending from the
free end of the limb which lies adjacent the anterior vaginal wall.
These protrusions have a depression therebetween. This depression
accommodates the anterior vaginal wall and the neck and base of the
bladder.
In use, the base portion blases the limbs outwardly to aid in
retention of the device in the vagina.
The limb adjacent the posterior vaginal wall preferably has two
legs at its free end. These legs are preferably curved and splayed in
order to fit over the perineal body for supporting the device in the
vagina.
Preferably, the opposing inner surfaces of the two limbs, are
covered by a spongy deformable material bearing complementary grooves
and ridges. This material imitates vaginal mucosa. Sexual intercourse
is therefore not effected by the device as the spongy material cannot
~ -4-
1 3229 1 3
readily be distinguished by the male partner. Additionally, the
grooves and ridges aid in channelling menstrual blood and vaginal
secretions through the vagina.
A further aspect of the present invention has the object of
providing an intra-vaginal device to aid in controlling urinary
incontinence.
There is disclosed herein an intra-vaginal device to aid in
controlling urinary incontinence in females, said device having a
central portion of an arcuate cupped configuration and shaped to be
retained, within the vagina of a user, in an upwardly convex
configuration, a rearward portion extending rearwardly from said
central portion to engage the posterior vaginal wall, a forward portion
extending upwardly from said central portion to engage the anterior
vaginal wall adjacent the bladder neck and to lift the bladder portion
located adjacent thereto, a bladder neck cradle provided by said
forward portion positioned to cradle the bladder neck, and wherein said
device is formed of resiliently deformable material so as to flex into
engagement with the posterior and anterior vaginal wall to retain the
device in its upwardly convex position with the forward portion lifting
the bladder and cradling the bladder neck.
Still further, it is preferred that the above described ring
would be adjustable in diameter.
In a still further aspect of the invention there is provided an
improvement in an entirely intravaginal urinary incontinence device
comprising a resilient annular body defining an annulus. The annular
body has integrally formed on respective portions thereof two
projections that project, at least in part, correspondingly
transversely to the annulus of the annular body and define therebetween
a cradle for engaging the anterior vaginal wall and lifting the bladder
adjacent the bladder neck.
The present invention will now be described by way of example
only with reference to the following drawings, in which:
Figure 1 is a perspective view of the intra-vaginal device;
Figure 2 is a side view of the intra-vaginal device;
Figure 3 is an end view of the intra-vaginal device;
Figure 4 is a schematic view of P saggital section of the female
pelvic organs showing the intra-vaginal device in place;
~ -5-
1 322~ t 3
Figure 5 is a schematic perspective view of an intra-vaginal
device to aid in controlling urinary incontinence;
Figure 6 is a schematic view of a saggital section of the female
pelvic organs showing the device of Figure 5 in place;
S Figure 7 is a schematic bottom plan view of a further intra-
vaginal device to aid in controlling urinary incontinence;
Figure 8 is a schematic section side elevation of the device of
Figure 7 sectioned along the line 8-8; and
Figure 9 is a schematic end elevation of the device of Figure 7.
The intra-vaginal device shown in Figure 1 is constructed of a
flexible material, for example a plastic/silicone compound.
The device comprises a base portion 10 which is of an arcuate
form. In this embodiment the base portion forms an arch 12 of
generally "U-shaped~ configuration. The base portion 10 may be
inherently resilient or may contain a resilient insert. The arch 12
contains an aperture 13 which in use is adjacent the cervix of the
uterus. The arch 12 interconnects two opposing limbs 14 and 16. The
limb 14 lies adjacent the anterior vaginal wall in use and has at its
end two opposed rounded projections 18 having a depression 20
therebetween to form a cradle-like structure.
The limb 16 extending from the arch 12 is of substantially planar
construction and has at its forward end a pair of splayed legs 22.
The flexible and resilient nature of the arch 12 enables the
device to be readily inserted into the vagina and aids in its retention
therein. Particularly, the arch 12 biases the limbs 14 and 16
outwardly, causing them to press against the anterior and posterior
walls of the vagina respectively, this holding the device in place.
As shown in Figure 4, when the device is inserted into the
vagina, the limb 14 lies adjacent to and supports the anterior vaginal
wall 24 preventing prolapse of the anterior vaginal wall (cystocele)
and prolapse caused by the bladder 25 pressing against the anterior
vaginal wall 24 (cysto-urethrocele). The outward bias of the limb 14
causes the projections 18 to cradle the anterior vaginal wall 24 and
lift the neck and base of the bladder above the pelvic floor muscle
thereby causing continence. Additionally, a significant closure of the
bladder nec~ is achieved as is a reduction of the included angle
--6--
X
1322~3
between the urethra and the bladder. These features again increase
continence.
The arch 12 supports the cardinal and uterosacral ligaments (not
shown) and helps to lift the uterus in the pelvic cavity thereby
preventing uterine prolapse. The aperture 13 in the arch 12 lies
adjacent the cervix of the uterus.
The limb 16 lies adjacent to and supports the posterior vaginal
wall 26, thereby preventing prolapse of the posterior vaginal wall 26
(enterocele) and rectal prolapse (rectocele). The legs 22 of the limb
14 rest on the posterior vaginal wall 26 in the region of the para-
rectal fossa 27. The splayed nature of the legs enables them to fit
over the perineal body, this aiding in retention of the device in the
vagina.
The device may be of different sizes to accommodate different
vaginal size. Preferably, those portions of the device contacting the
vaginal wall are smeared with Disaestrol and Sultril cream in order to
minimize vaginal irritation.
In a further embodiment of the present invention as shown in
Figs. 5 and 6, a small inflatable balloon 28 may be provided between
the projections 18. The balloon may be inflated to compress the
bladder neck against the pubic symphysis thus closing off the urethra
resulting in continence. The balloon 18 may be inflated/deflated by
virtue of a small lead connected to the balloon which passes out of the
vagina where it can be manipulated by the patient.
In Figures 7 to 9 there is schematically depicted an intra-
vaginal device to aid in controlling urinary incontinence. The device
30 is formed of resilient material so that in use it is resiliently
deformed within the vagina so as to be biased outward into contact with
the posterior and anterior vaginal wall. The device is about 8 cm in
diameter. The device 30 includes a central portion 31 of an arcuate
cupped configuration having an aperture 32 to allow for the discharge
of menstrual blood and vaginal secretions.
Extending rearwardly from the central portion 31 is a rear
portion 33 which in this particular embodiment comprises a pair of
rearwardly extending projections 34.
Also extending from the central portion 31, is a forwsrd portion
35 which projects generally upwardly and in use, extends both forwardly
1 32~q 1 3
and upwardly to engage the anterior vaginal vall adjacent the bladder
neck. The forward portion 35 includes a pair of upwardly estending
projections 36 which engage the anterior vaginal wall to lift the
bladder adjacent the bladder neck. The projections 36 are about 2 cm
high. Defined between the portions 36 is a cradle 37 within which the
bladder neck lies to be cradled thereby. It should be appreciated that
the pressures applied to the bladder neck are minimized by the cradle
neck 37.
Preferably the device 37 would be integrally formed of moulded
elastomeric material having sufficient resilience so that upon being
deformed and inserted in the vagina, the rear portion 33 and forward
portion 35 are resiliently biased into contact with the posterior and
anterior wall of the vagina.
The central portions 31 have sides 38 which also engage the sides
of the vaginal wall to aid in retaining the device 30 in position, that
is concaved upwardly so that the forward portion 36 engages the
anterior vaginal wall adjacent the bladder.
In the above embodiment the device 30 is performed so as to be
~cup~ shaped. However, the central portion 31 could be of a more
planar configuration, so that in position within the vagina it is
resiliently deformed into an arcuate or ~cup~ shaped configuration.
The above discussed preferred embodiments of the present
invention have the advantage that they may be placed in position by a
medical practitioner without anaesthetic, with immediate results
achievable.
